BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COFLEX INTERLAMINAR TECHNOLOGY

    MDR report key: 14767115 · Received June 22, 2022

    Report

    Report Number
    3005725110-2022-00001
    Event Type
    Injury
    Date Received
    June 22, 2022
    Date of Event
    May 24, 2022
    Report Date
    January 26, 2023
    Manufacturer
    PARADIGM SPINE GMBH
    Product Code
    NQO
    UDI-DI
    04260148898532
    PMA / PMN Number
    P110008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PATIENT WAS TREATED WITH COFLEX IMPLANTS IN THE LEVELS L3/L4 AND L4/L5 IN 2017 AND THE PATIENT REPORTED FEELING GREAT WITH NO BACK PAIN UNTIL APPROXIMATELY 2019 WHEN HE NOTED INCREASED BACK PAIN. THE PATIENT PRESENTED TO THE SURGEON A MONTH BEFORE THE REVISION SURGERY AND THE SURGEON RECOGNIZED THE FRACTURED IMPLANT AT THE L4/L5 LEVEL IN THE SAGITTAL RADIOGRAPH. THE SURGEON DETERMINED THAT A REVISION LUMBAR SURGERY WAS THE PREFERRED TREATMENT TO REDUCE THE PATIENT'S PAIN AND RESTORE STABILITY. THE IMPLANT WAS REMOVED WITH ADDITIONAL DECOMPRESSION PERFORMED. THE SURGEON DETERMINED THE PATIENT HAD SUFFICIENT STABILITY WITHOUT THE NEED FOR FUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2158397 COFLEX INTERLAMINAR TECHNOLOGY PROSTHESIS, SPINOUS PROCESS SPACER NQO PARADIGM SPINE GMBH UQI00014 2016000286 04260148898532

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Male Required Intervention